Last updated: December 7, 2020
Sponsor: Bucci Laser Vision Institute
Overall Status: Completed
Phase
4
Condition
Eye Disease
Eye Disorders/infections
Vision Loss
Treatment
N/AClinical Study ID
NCT01296542
2011-BV-C
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Man or woman 18 years of age or older.
- Physically capable of instilling eye drop or have an appropriate person available toassist in administration of eye drops 4 times a day.
- Scheduled for phacoemulsification with intraocular lens (IOL) implantation for thetreatment of cataract.
- Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and bemedically cleared for surgery.
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- Subjects must have signed an informed consent document indicating that they understandthe purpose of and procedures required for the study and are willing to participate inthe study.
Exclusion
Exclusion Criteria:
- Known allergy or contraindication to the test article(s) or their components.
- Presence of any abnormality or significant illness in the eye that in theinvestigator's opinion could affect the subject's health or the study parameters.
- Presence of an active ocular infection (bacterial, viral or fungal), or positivehistory of ocular herpetic infection.
- History of any significant illness that could be expected to interfere with the studyparameters. Any condition that, in the opinion of the investigator, would compromisethe well-being of the subject or the study.
- Use of disallowed therapies (systemic or topical):
- Fluoroquinolone anti-infective agents (systemic or topical) within 1 week ofVisit 1 or anytime after Visit 1 for the duration of the study.
- Use of contact lenses for one week prior to the study and for the duration of thestudy.
- Received an experimental drug or used an experimental medical device within 21 daysbefore the planned start of treatment.
Study Design
Total Participants: 60
Study Start date:
May 01, 2011
Estimated Completion Date:
January 31, 2013
Connect with a study center
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania 18702
United StatesSite Not Available

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